Responsibilities:Support Nonconforming Material and CAPA programs.Support Complaint program 21 CFR Part 820, ISO 13485 ISO 14971, MDD 93/42/EEC and EU MDR 22017/745 and 746Provide support in all internal, external, and supplier audit activitiesParticipate in continuous improvement projects as neededImplement & maintain policies and procedures to ensure continuous compliance to MVE's Quality Management System.Implement quality strategies for modified and new product development.Implement methods and systems to assure that MVE's development and manufacturing teams receive support in the areas of risk management, design controls including validation and verification testing, corrective and preventative action, root cause analysis, statistical analysis, quality planning and inspection processes.Collaborate with cross-functional teams to maintain adherence to the Quality Management System during planning, execution, and implementation activities for Engineering initiatives.Oversee product and manufacturing changes (Change Control) for compliance with applicable regulations and potential impact on future and current regulatory submissions.Participate in the product development process to assure products are designed in compliance with the appropriate regulations and applicable international quality systems standardsImplement Quality Systems metrics and evaluation processes and reporting of these metrics to MVE Management Team.Establishing and maintaining Key Performance Indicators.Problem solving with a clear understanding of compliance requirements and the ability to collect objective evidence for investigations can help solve problems, typically in situations where general standardization should exist, but may not be operating effectively.Provide daily quality system support activitiesRequirements:Bachelor's Degree in an engineering field or other technical science.10 years prior experience in Quality Assurance and Regulatory Affairs.Strong attention to detail.Demonstrated experience working with regulatory bodies, contract manufacturers, suppliers and distributors.Comfortable working within a fast growth and changing environment.Demonstrated ability to effectively communicate and influence decision makers.Experience in quality systems and audits.Knowledge of various Quality System and Regulatory Standards that are applicable to GMP Compliance.Experience working in cross functional organizations.Strong communication and interpersonal skills.Excellent written and verbal communication skills with the ability to listen, articulate and advocate.Proactive, high-performance result oriented and ability to manage projects with ethical integrity.Manage multiple projects and deadlines.Ability to identify compliance risks and escalate when necessary.Demonstrate both creative and critical thinking skills.Hold a Six Sigma Green Belt or Black Belt or willingness to work towards attainment.ASQ Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) preferred.Advanced training/experience in the use of statistical techniques and process improvement methods.
